MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Catalog Number	366643
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) plus blood collection tubes, sixteen (16) tubes underfilled.There were no health impact or consequences reported.
Additional Manufacturer Narrative
D2b.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.The information for the additional 510k is as follows: g.4.Pma/510(k)#: k213670, k231373.A device evaluation is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) plus blood collection tubes, sixteen (16) tubes underfilled.There were no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 29-nov-2024.Investigation summary: bd received fifty-nine (59) samples and two (2) photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for underfill was not observed.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for underfill with the incident lot was not observed.20 returned samples were draw-tested with deionized water.From this testing, it was determined that all 20 tubes drew within specification.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of underfill.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20905127
• Report Number: 9617032-2024-01910
• Device Sequence Number: 18436913
• Product Code: GIM
• UDI-Device Identifier: 30382903666431
• UDI-Public: (01)30382903666431(11)240308(17)250228(10)4068286
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK230980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 366643
• Device Lot Number: 4068286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown